|
| FDA approved TB drugs with ARVs | |
|
| Rifampicin (RMP) | |
| (i) Evaluation of double-dose LPV/r (800/200 twice daily) among HIV/TB-coinfected adults taking RMP-containing TB treatment with focus on HIV viral suppression and hepatotoxicity | |
| (ii) Evaluation of super-boosted LPV (1: 1 LPV/r ratio with weight-based dosing) among HIV/TB-coinfected children receiving RMP-containing TB treatment with focus on LPV PK and HIV viral suppression | |
| (iii) Evaluation of EFV at 600 mg versus 800 mg daily among patients with HIV/TB-coinfection taking RMP-containing TB treatment who weigh more than 50 kg | |
| (iv) Evaluation of EFV or higher dose LPV/r among pregnant women with HIV/TB-coinfection taking RMP-containing TB treatment | |
| (v) Evaluation of double-dose RAL (800 mg twice daily) among HIV/TB-coinfected patients taking RMP-containing TB treatment | |
| (vi) Determination of dose of DRV/r likely to achieve target DRV concentrations among subjects taking RMP | |
| (vii) Evaluation of higher dose dolutegravir (50 mg twice daily) among HIV/TB-coinfected patients taking RMP-containing TB treatment | |
|
| Rifapentine (RPT) | |
| (i) Drug interaction studies involving RPT at the optimized dose for TB treatment and key HIV drugs, namely, EFV, NVP, and ritonavir-boosted PIs | |
| (ii) Drug interaction studies with weekly RPT used for LTBI treatment and key ARVs including EFV, NVP, and ritonavir-boosted PIs among patients with HIV receiving ART | |
| (iii) Dose-finding PK study in infants and pediatric formulations | |
|
| Rifabutin (RBT) | |
| (i) Evaluation of RBT at a dose of 150 mg daily among HIV-TB-coinfected patients taking LPV/r-based ART with a focus on RBT-related toxicities and HIV viral load suppression | |
| (ii) RBT formulations for children | |
|
| Isoniazid (INH) | |
| (i) Studies of the effects of INH (alone) as treatment for LTBI on the kinetics of EFV and LPV/r | |
|
| Select Tb drugs in the pipeline | |
|
| AZD5847 | |
| (i) PKI studies as appropriate once the dose to be tested in later-phase studies is determined and information regarding its metabolism and capacity to induce or inhibit P450 enzymes is publicly available | |
|
| Bedaquiline (TMC207) | |
| (i) PK/PD studies among patients with TB/HIV coinfection taking bedaquiline-containing TB treatment and ART that includes EFV or NVP (multiple dose study) | |
| (ii) Dose-finding PK study in children with MDR-TB | |
| (iii) PKI with combined use of RMP and EFV with bedaquiline | |
|
| Delamanid (OPC-67683) | |
| (i) No specific drug interaction studies currently recommended given low risk of metabolic drug interactions | |
|
| PA-824 | |
| (i) Drug interaction studies with RMP, EFV, and LPV/r with necessity of further studies to be determined by results of these trials of PA-824 given with a potent inducer (RMP) or potent inhibitor (ritonavir) | |
|
| Sutezolid (PNU-100480) | |
| (i) Drug interaction study with RMP and perhaps key ARVs once dose to be tested in later-phase studies is determined, with measurement of parent drug and active metabolites | |
| (ii) Dose-finding PK study in children | |
|
| SQ109 | |
| (i) PKI study with RMP once the dose of SQ-109 to be tested in later-phase studies is determined | |
|
